Have you ever wanted to make a difference?
At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
Abbott Ireland
In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway.
Vascular Division Clonmel
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular Clonmel is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals. Our broad line of vascular devices manufactured in Clonmel includes vessel closure, endovascular and coronary technologies designed to treat heart attack, stroke, critical limb ischemia and other serious vascular conditions.
Purpose Statement
The Compliance Manager is responsible for maintaining the Clonmel activities as part of the internal audit programme to effectively assess and report on the business units compliance status relative to defined quality system requirements. Primary responsibilities include planning activities needed to assess the status of the quality system, organising resources appropriate to execute the identified plan, approving documentation of the assessment results and corrective action taken, and reporting the status results to management. You will also support the quality system by taking action to align activities with corporate compliance objectives, by facilitating inspections with outside regulatory agencies, and by other tasks as assigned by management.
Key Responsibilities
1. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
2. Keeps the organisations vision and values at the forefront of decision making and action.
3. Builds strategic partnerships to further departmental and organisational objectives.
4. Assists in creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
5. Monitors compliance with company policies and procedures (e.g. compliance with Food and Drug Administration (FDA), British Standards Institution (BSI), Equal Employment Opportunity (EEO) regulations).
6. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
7. Develops, monitors and appropriately adjusts the annual budget for department(s).
8. Communicates to management the compliance status of the business units quality system through the quality systems review meetings.
9. Facilitates inspections of the business unit by outside regulatory agencies, including any required responses.
10. Establish and maintain effective structures to ensure consistent implementation of the quality system for Abbott Vascular (AV) Clonmel as the site of legal manufacture.
Job Skills And Education
1. National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.
2. 6+ years of related work experience or an equivalent combination of education and work experience.
3. Identifies and acts upon trends that can impact the business. Creates and communicates a motivating compelling vision of the future that supports employee engagement.
4. Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. Takes initiative to implements change before others.
5. Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action.
6. Creates a sustainable infrastructure and environment that enables growth.
7. Displays continuous energy, intensity and persistence to drive the organisation forward.
8. Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
9. Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments.
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